Ekbom Syndrome Clinical Trial
Official title:
The Use of the Vasculaire Leg Compression Device for the Treatment of Restless Legs Syndrome - A Prospective Clinical Study
Restless legs syndrome (RLS) is a debilitating sleep disorder that has significant impact on quality of life, and often times can be difficult to diagnose and treat effectively. RLS is typically treated with medical therapy (including dopaminergic agents, dopamine agonists, benzodiazepines, anticonvulsants, opiates, among other therapies). Many patients are either refractory to medical therapy, have contraindications or adverse reactions to the available medical therapies, or desire conservative non-medication based therapies. Two previous studies have demonstrated that pneumatic compression devices placed on the legs can improve symptoms of RLS. We would like to assess whether the Venous Health Systems Vasculaire leg compression device improves symptoms and quality of life measures related to RLS in up to 40 patients evaluated prospectively for one month. This is a pilot study to assess the subjective response of our cohort of patients to this device prospectively. Our hypothesis is that over 66% of our cohort will demonstrate a positive symptomatic response based on RLS specific quality of life questionnaires.
BACKGROUND:
Restless Leg Syndrome (RLS) affects nearly 12 million Americans. Although the precise
etiology of RLS is not well characterized, there are specific diagnostic criteria. Symptoms
are typically worse in the evening, consisting of a strong urge to move the affected limb(s)
and relief with movement. Current medical therapies pose several challenges for many
patients, as side effects include extreme drowsiness, hallucinations, nausea, headaches and
insomnia. An alternative, non-medical therapy may provide a suitable option to this subset
of patients. Intermittent pneumatic compression devices have previously been studied in this
population, and have demonstrated effectiveness. However prior models have required subjects
to remain immobile during use, representing a significant limitation given that immobility
may actually promote worsening of symptoms. An effective, alternative non-pharmacologic
therapy that does not interfere with patient mobility should provide a valuable treatment
option.
The purpose of this study is to assess whether the Vasculaire Intermittent Pneumatic
Compression System will improve validated measures of symptom relief, patient satisfaction,
and quality of life for RLS. This is a pilot study to determine whether or not the
Vasculaire device improves validated measures of symptom relief, patient satisfaction, and
quality of life in RLS patients. Depending on the outcome of our study we hope to develop a
sham-controlled clinical trial as a follow-up study.
METHODS:
We are performing a Prospective cohort study.
We will recruit patients until we reach an N=40.
After informed consent, the patient's record will be reviewed to ensure that they have had a
serum iron panel and ferritin checked within the preceding 6 months. For those patients
missing these laboratory studies, they will have their blood drawn for a full serum iron
panel (serum iron level, serum ferritin, and total iron binding capacity), as per standard
of care (to exclude iron deficiency as a cause or contributor to their symptoms). Patients
with inadequate serum iron stores will be excluded. Patients with adequate iron stores will
be asked to complete a comprehensive medical questionnaire to document medical conditions
and medications with doses prescribed.
This questionnaire will also record previously tried therapies, both home remedies and
medically prescribed treatments. Specific undesirable side effects will also be documented.
Severity will then be determined based on 5 previously validated questionnaire instruments
(The Restless Legs Syndrome Rating Scale, The Restless Legs Syndrome-Quality of Life
Instrument (RLS-QLI), The Epworth Sleepiness Scale (ESS), The Johns Hopkins Restless Legs
Severity Scale (JHRLS), The International Restless Legs Syndrome Rating Scale).
Once the medical history has been reviewed, documentation of severity assessed and the
determination of unresolved treatment post medical therapy, the patient will be eligible for
enrollment.
The Vasculaire Intermittent Pneumatic Compression System will be introduced to the patient
and instructions provided on how to optimize the use of device in accordance with the study
protocol.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01976871 -
Switching From Oral Dopamine Agonists to Rotigotine
|
Phase 4 |